Pharmacology Chapter 3
| Which legislation set rules for the manufacture and distribution of drugs considered to have the potential for abuse?|
A) Food, Drug, and Cosmetic Act of 1938
B) Harris-Kefauver Amendments of 1962
C) Controlled Substances Act of 1970
D) Food and Drug Administration Modernization Act of 1997
| Correct: C|
The Controlled Substances Act of 1970 set rules covering drugs of abuse and defined categories of controlled substances.
|What is a result of the Prescription Drug User Fee Act (PDUFA) of 1992?|
A) New drugs reach the market sooner than ever before.
B) Controlled substances are categorized into schedules.
C) Drugs for acquired immunodeficiency syndrome (AIDS) receive accelerated approval.
D) More research is conducted on drug safety in children.
PDUFA was a response to complaints about the length of time required for approval of new drugs by the U.S. Food and Drug Administration (FDA). Under this act, drug sponsors pay fees to the FDA that are used to fund additional reviewers. The FDA then must adhere to strict turnaround times for drug review processes.
|Which is a true statement about new drug development in the United States?|
A) Development and testing of new drugs take about 3 to 5 years.
B) About 50% of drugs undergoing clinical trials gain approval.
C) Randomized controlled trials are the best way to assess drug therapy.
D) The cost of developing a new drug is usually around $1 million.
| Correct: C|
New drug development takes about 6 to 12 years, and costs can exceed $ 1 billion. Only about 1 in 5 drugs undergoing clinical trials gains approval. Randomized controlled trials are the most reliable way to objectively assess drug therapies and are used to evaluate all new drugs.
| N-acetyl-para-aminophenol is an example of which type of drug name?|
The chemical name is a description of a drug using the nomenclature of chemistry. The proprietary or trade name of the drug is the brand name under which the drug is marketed by one or more companies. The generic name is the name assigned by the U.S. Adopted Names Council and is the same regardless of who manufactures the drug.
|A new medication becomes available for treatment of a debilitating neurologic disease. What would the nurse expect about the safety of the drug?|
A) The drug is safe for administration to children.
B) The drug has been tested in pregnant women.
C) All possible adverse effects have been identified by animal testing.
D) The drug has passed the FDA approval process.
| Correct: D|
A new medication must meet the FDA's stringent requirements before it comes to market. Most drugs have not been tested in women (including pregnant women) or children. Animal testing cannot identify all possible adverse effects.
|Why are trade names much easier to say and remember than generic names?|
A) The FDA assigns every drug's generic name.
B) Trade names must be the same regardless of which drug company manufactures the drug.
C) Companies have a marketing advantage when the trade name is easier to recognize.
D) Trade names improve oral and written communication in the healthcare system.
The U.S. Adopted Names Council assigns a drug's generic name. Generic names, not trade names, are the same regardless of which company manufactures the drug. Trade names do not contribute to ease and clarity of communication in the healthcare system, because healthcare professionals do not always know what compound is described by the trade name.
| What term is commonly used for nonprescription drugs?|
| Correct: C|
Over-the-counter (OTC) drugs are also known as nonprescription drugs.
|Which is a true statement about new drug development? (Select all that apply.)|
A) Preclinical testing of drugs is always performed in healthy, nonpregnant adults.
B) Drug trials require that those involved not know which subjects are receiving the drug or control.
C) During preclinical testing, drugs are evaluated for toxicities, kinetic properties, and useful effects.
D) When a new drug is released, all adverse effects are known.
|Correct: B, C|
Preclinical drug testing is not performed in humans; it is done mostly in animals. Because drug testing occurs in a relatively small number of patients, those patients are carefully selected, the drug is taken for a relatively short time, and not all adverse effects are detected during the drug testing process. During the testing process, randomized controlled trials are used, in which the participants are unaware of which subjects are getting drug, placebo, or control. Kinetics, toxicities, and effectiveness are tested during the preclinical phase of drug testing.
|Which statement about over-the-counter (OTC) drugs would the nurse identify as true? (Select all that apply.)|
A) Most illnesses initially are treated with an OTC agent.
B) More prescription drugs than OTC agents are administered each year in the United States.
C) The average home medicine cabinet contains eight OTC preparations.
D) Forty percent of Americans take at least one OTC drug every 2 days.
E) Some drugs that originally were sold by prescription are now OTC.
| Correct: A, D, E|
Most illnesses are initially treated with an OTC agent. OTC drugs account for 60% of all doses administered. The average home medicine cabinet contains 24 OTC preparations.
|Which statement about the Family Smoking Prevention and Tobacco Control Act (2009) would the nurse identify as true? (Select all that apply.)|
A) All ingredients in tobacco products must be listed on the warning label.
B) A gradual reduction of nicotine to nonaddictive levels is required.
C) Marketing to youth is prohibited.
D) Harmful additives are restricted.
E) Purchasers of tobacco products must be age 21 years or older.
| Correct: A, B, C, D|
All of the statements about the Family Smoking Prevention and Tobacco Control Act (2009) are true except option E. The legal age for purchasing tobacco products, as set by the act, is 18 years.